Intrathecal Hydromorphone for Postoperative Pain of Anorectal Surgery

NCT ID: NCT05579223

Last Updated: 2024-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-17
• Study Completion Date: 2024-01-27

Brief Summary

Anorectal problems, such as hemorrhoids, fistula, fissures, Etc., often require surgical treatment. Patients often have postoperative pain after these surgeries, which increases discomfort and hospital length of stay. The efficacy of oral non-opioids in the treatment of such pain is poor. Hydromorphone is an opioid analgesic commonly used orally or intravenously for postoperative pain management. We designed this trial to investigate the efficacy and safety of intrathecal (delivery directly to the spinal cord during spinal anesthesia) single dose hydromorphone versus intrathecal placebo in treating postoperative pain among human subjects after anorectal surgery, but also the recovery of postoperative motor capacity in these human subjects.

Conditions

Acute Pain; Post Operative Pain; Anorectal Disorder; Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intrathecal Hydromorphone Group (ITHM)

Dosage Form: Hydromorphone Hydrochloride Injection 2mg:2ml. Dosage: 75 μg+ 5% glucose injection diluted to 1.5ml. Frequency and Duration: i.t., st

Group Type: EXPERIMENTAL

Intrathecal Hydromorphone Mono Injection

Intervention Type: DRUG

Experimental Drug: Hydromorphone Hydrochloride Injection. Administration: subarachnoid space mono bolus inject, + 5% glucose injection diluted to 75 μg:1.5ml, Speed ≤ 0.5 ml/s

Intrathecal Placebo Group (ITPO)

Dosage Form: 5% glucose injection, 100ml/Package. Dosage: 1.5ml. Frequency and Duration: i.t., st

Group Type: PLACEBO_COMPARATOR

Intrathecal Placebo Mono Injection

Intervention Type: DRUG

Placebo: 5% glucose injection. Administration: subarachnoid space mono bolus inject, 1.5ml, Speed ≤ 0.5 ml/s

Interventions

Intrathecal Hydromorphone Mono Injection

Experimental Drug: Hydromorphone Hydrochloride Injection. Administration: subarachnoid space mono bolus inject, + 5% glucose injection diluted to 75 μg:1.5ml, Speed ≤ 0.5 ml/s

Intervention Type: DRUG

Intrathecal Placebo Mono Injection

Placebo: 5% glucose injection. Administration: subarachnoid space mono bolus inject, 1.5ml, Speed ≤ 0.5 ml/s

Intervention Type: DRUG

Other Intervention Names

ITHM; ITPO

Eligibility Criteria

Inclusion Criteria

• 1. Clinical Diagnosis of anorectal disease, ready to undergo elective surgery
• 2. American Society of Anesthesiologists(ASA) physical status I-II
• 3. Desire to have a spinal anesthesia
• 4. Must be able to follow the medication dose and visit schedule

Exclusion Criteria

• 1. Any contraindications to spinal anesthesia and intrathecal analgesia.
• 2. Complex co-morbidities, including

1. Severe infection,

2. Respiratory insufficiency,

3. History of psychiatric or neurological disorders and other cognitive impairments

• 3. Chronic pain syndrome or current opioid use >10mg oral morphine equivalents/day
• 4. Allergy or intolerance to hydromorphone, NSAIDs and Cox-2 selective Inhibitor
• 5. Clinical diagnosis of obstructive sleep apnea syndrome(OSAS)
• 6. History of drug abuse
• 7. Women who are breastfeeding or pregnant
• 8. Participation in other clinical trials within three months
• 9. Already participated in this study once
• 10. Not considered suitable for the clinical trial by the investigators

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jiangtao Xu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Locations

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

XH-22-005

Identifier Type: -

Identifier Source: org_study_id